The Compounding Pharmacy of America recalls MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Kno
Recalled September 23, 2015 · FDA recall D-1739-2015 · The Compounding Pharmacy of America
Hazard
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility · FDA Class II
Units
218 ml
Sold at
Nationwide
Description
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product
MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer(s)
The Compounding Pharmacy of America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →